Human spinal disc prothesis with hinges

ABSTRACT

The invention relates to a spinal disc endoprosthesis. The endoprosthesis has a resilient body formed of one or more materials which may vary in stiffness from a relatively stiff exterior annular gasket portion to a relatively supple central nucleus portion. Concaval-convex elements at least partly surround that nucleus portion so as to retain the nucleus portion and gasket between adjacent vertebral bodies in a patient&#39;s spine. Assemblies of endoprosthetic discs, endoprosthetic vertebral bodies, and endoprosthetic longitudinal ligaments may be constructed. To implant this endoprosthesis assembly, information is obtained regarding the size, shape, and nature of a patient&#39;s damaged spine. Thereafter, one or more prosthetic vertebral bodies and disc units are constructed in conformity with that information. Finally, the completed and conformed vertebral body and disc assembly is implanted in the patient&#39;s spine.

This is a continuation-in-part of U.S. patent application Ser. No.08/681,230, filed Jul. 22, 1996, now U.S. Pat. No. 5,674,296 and whichis a continuation-in-part of U.S. patent application Ser. No.08/339,490, filed Nov. 14, 1994, which is abandoned.

BACKGROUND OF THE INVENTION

This invention relates generally to human prostheses, and especially tospinal column vertebral intervertebral disc prostheses. The inventionalso relates to surgical procedures for preparing the patient to receivea vertebral an intervertebral disc endoprosthesis, and for implantingthat endoprosthesis in the patient's spine.

The herniation of a spinal disc and the often resultant symptoms ofintractable pain, weakness, sensory loss, incontinence and progressivearthritis are among the most common of debilitating processes affectingmankind. If a patient's condition does not improve after conservativetreatment, and if clear physical evidence of nerve root or spinal cordcompression is apparent, and if correlating radiographic studies (i.e.,MRI or CT imaging or myelography) confirm the condition, surgicalremoval of the herniated disc may be indicated. The process ofdiscectomy—as the name implies—involves the simple removal of the discwithout attempt to replace or repair the malfunctioning unit. In theUnited States in 1985, over 250,000 such operations were performed inthe lumbar spine and in the cervical spine.

Statistics suggest that present surgical techniques are likely to resultin short-term relief, but will not prevent the progressive deteriorationof the patient's condition in the long run. Through better pre-operativeprocedures and diagnostic studies, long-term patient results haveimproved somewhat. But it has become clear that unless the removed discis replaced or the spine is otherwise properly supported, furtherdegeneration of the patient's condition will almost certainly occur.

In the mid-1950's and 60's, Cloward and Smith & Robinson popularizedanterior surgical approaches to the cervical spine for the treatment ofcervical degenerative disc disease and related disorders of thevertebrae, spinal cord and nerve root; these surgeries involved discremoval followed by interbody fusion with a bone graft. It was noted byRobinson (Robinson, R. A.: The Results of Anterior Interbody Fusion ofthe Cervical Spine, J. Bone Joint Surg., 440A: 1569-1586, 1962) thatafter surgical fusion, osteophyte (bone spur) reabsorption at the fusedsegment might take place. However, it has become increasingly apparentthat unfused vertebral segments at the levels above and below the fusedsegment degenerate at accelerated rates as a direct result of thisfusion. This has led some surgeons to perform discectomy alone, withoutfusion, by a posterior approach in the neck of some patients. However,as has occurred in surgeries involving the lower back where discectomywithout fusion is more common as the initial treatment for discherniation syndromes, progressive degeneration at the level of discexcision is the rule rather than the exception. Premature degenerativedisc disease at the level above and below the excised disc can and doesoccur.

Spine surgery occasionally involves fusion of the spine segments. Inaddition to the problems created by disc herniation, traumatic,malignant, infectious and degenerative syndromes of the spine can betreated by fusion. Other procedures can include bone grafts and heavyduty metallic rods, hooks, plates and screws being appended to thepatient's anatomy; often they are rigidly and internally fixed. Noneprovide for a patient's return to near-normal functioning. Though theseprocedures may solve a short-term problem, they can cause other, longerterm, problems.

A number of attempts have been made to solve some of the problemsdescribed above by providing a patient with spinal disc prostheses, orartificial discs of one sort or another. For example, Steffee, U.S. Pat.No. 5,031,437, describes a spinal disc prosthesis having upper and lowerrigid flat plates and a flat elastomeric core sandwiched between theplates. Frey et al., U.S. Pat. Nos. 4,917,704 and 4,955,908, discloseintervertebral prostheses, but the prostheses are described as solidbodies.

U.S. Pat. Nos. 4,911,718 and 5,171,281 disclose resilient disc spacers,but no inter-connective or containing planes or like elements aresuggested, and sealing the entire unit is not taught.

It is the primary aim of the present invention to provide a vertebral anintervertebral disc endoprosthesis which will perform effectively andefficiently within a patient's spine over a long period of time, andwhich will not encourage degeneration of or cause damage to adjacentnatural disc parts.

It is a related objective to provide a new vertebral intervertebral discendoprosthesis surgical procedure which will decrease post-operativerecovery time and inhibit post-operative disc, vertebral body and spinaljoint degeneration.

It is yet another object to provide a method of installing theendoprosthesis so as to accurately mate the endoprosthesis with anadjacent specifically formed bone surface. An associated object is toprovide an endoprosthesis which will encourage bone attachment to, andgrowth upon, adjacent outer surfaces of the endoprosthesis.

Yet another object is to provide a vertebral endoprosthesis in which theparts are non-oncogenic.

Still another object is to provide a vertebral an intervertebral discendoprosthesis having a resilient element to accommodate shocks andother forces applied to the spine.

Another object is to provide a highly effective vertebral endoprosthesiswhich includes several disc endoprostheses and one or more prostheticvertebral bodies. A related object is to provide these elements in apre-assembled array for implantation in a patient.

SUMMARY OF THE INVENTION

To accomplish these objects, the invention comprises a resilient bodyformed of a material varying in stiffness from a relatively stiffexterior portion to a relatively supple central portion. Aconcaval-convex means at least partly surrounds that resilient body soas to retain the resilient body between adjacent vertebral bodies of apatient's spine. If medical considerations so indicate, several discendoprostheses can be combined with one or more endoprosthetic vertebralbodies in an entire assembly.

To implant this endoprosthesis assembly, information is obtainedregarding the size, shape, and nature of a patient's damaged naturalspinal discs. If one or more of the patient's vertebral bodies alsorequire replacement, information about those bodies is also obtained.Thereafter, one or more prosthetic disc units and interposed prostheticvertebral body units are constructed and preassembled in conformity withthat information. Finally, the completed and conformed prosthetic discand vertebral body assembly is implanted in the patient's spine.

Other objects and advantages of the invention will become apparent uponreading the following detailed description and upon reference to thedrawings. Throughout the drawings, like reference numerals refer to likeparts.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary vertical view of a portion of a human spine inwhich is installed a novel vertebral disc endoprosthesis embodying thepresent invention;

FIG. 2 is a fragmentary side elevational view similar to FIG. 1 showingthe elements of a patient's spine and having a novel vertebral discendoprosthesis embodying the present invention installed therein;

FIG. 3 is a sectional view taken substantially in the plane of line 3-3in FIG. 1;

FIG. 4 is an exploded view of the novel vertebral disc endoprosthesis;

FIG. 5 is a vertical fragmentary view of a patient's spine similar toFIG. 1, but showing a series of novel disc endoprosthesis unitsinstalled in the spine and interconnected to one another;

FIG. 6 is a fragmentary sectional view of a patient's spine similar toFIG. 3 and taken along line 6-6 in FIG. 5, but showing a natural uppervertebral body, and upper endoprosthetic disc; an adjacentendoprosthetic vertebral body; a second or lower endoprosthetic disc;and a second or lower natural vertebral body;

FIG. 7 is a sectional view taken substantially in the plane of line 7-7of FIG. 6;

FIG. 8 is a fragmentary side elevational view of the assembly shown inFIG. 6; and

FIG. 9 is a fragment vertical view, similar to FIG. 1, of a portion of ahuman spine in which is installed a variant form of the novel vertebraldisc endoprosthesis the variant form having a prosthetic longitudinalligament;

FIG. 10 is a sectional view taken substantially in the plane of line10-10 in FIG. 9;

FIG. 11 is a top view of a retainer means for use with a vertebral discendoprosthesis;

FIG. 12 is a sectional view taken substantially in the plane of line12-12 of FIG. 11;

FIG. 13 is a side view of a vertebral disc endoprosthesis having agroove for receiving the retainer means; and

FIG. 14 is a cross-sectional view of the retainer means in use.

DETAILED DESCRIPTION

While the invention will be described in connection with a preferredembodiment and procedure, it will be understood that it is not intendedto limit the invention to this embodiment or procedure. On the contrary,it is intended to cover all alternatives, modifications, and equivalentsas may be included within the spirit and scope of the invention asdefined by the appended claims.

Turning more specifically to FIGS. 1-3, a portion of a human spine 10 isshown. The illustrated spine 10 has been subjected to a discectomysurgical process. To discourage degeneration of or damage to the naturalvertebral bodies 12 and 14 and their respective facet joints, inaccordance with the invention, a vertebral an intervertebral discendoprosthesis 18 is affixed between the adjacent natural vertebralbodies 12 and 14. Here this vertebral intervertebral disc endoprosthesis18 comprises a resilient disc body 20 having a relatively stiff annulargasket exterior portion 22 and a relatively supple nuclear centralportion 24. The annular gasket 22 can be formed from a suitablebiocompatible elastomer in the range of approximately 70-90 durometerhardness and the nuclear central portion 24 can be formed from a softerbiocompatible elastomeric polymer of approximately 30 durometerhardness. In an alternate embodiment, the gasket 22 can extend over andunder the nuclear central portion 24 so as to fully enclose it within athin layer. In a further embodiment, the nuclear central portion, thegasket, and the thin layer extension are molded together to form onepiece having different durometer hardnesses.

Concaval-convex means 30 surround the resilient body 20 to retain theresilient body 20 between the adjacent natural vertebral bodies 12, 14in a patient's spine 10. To this end, as shown in FIG. 3, theconcaval-convex means 30 comprise two generally L-shaped supports 32 and34. The supports 32, 34 each have confronting first concaval-convex legs42, 44, each leg being of relatively constant cross-sectional thickness.Each leg 42, 44 has an outer convex surface 52, 54 for engaging theadjacent bone of the natural vertebral bodies 12, 14. Correspondinginner concave surfaces 62, 64 in confronting array retain the resilientbody 20 in its illustrated compressive force shock-absorbing position.These supports 32 and 34 can undergo principle movement away from oneanother, but only limited secondary translational, rotational anddistractional motion will occur. Each support 32, 34 has a second wingor leg 72, 74 extending generally perpendicularly to the first legs 42,44 respectively, and adapted for affixation to the adjacent bonestructure. To carry out aspects of the invention described below, thisaffixation is effectively accomplished by cannulated screw devices 82,84 which may be of a biodegradable type manufactured by Zimmer of Largo,Fla. Each device 82, 84 comprises a screw 92, 94; and a screw anchor102, 104 adapted to threadably receive the screw extends radially intoand seats within the bone structure 12, 14 as especially shown in FIG.3. The screws 92, 94 may terminate in the anchor or alternately proceedthrough an open ended anchor and terminate in the bone of the vertebralbody 12, 14 directly. The anchors 102, 104 may be close-ended, openended, or of the expansion type.

To discourage and prohibit migration of fluids between theendoprosthesis 18 and adjacent parts of the anatomy, a seal member 110is attached to the supports 32, 34 so as to surround the resilient body20 which is comprised of the gasket 22 and nucleus 24, in accordancewith another aspect of the invention. Here, this seal member 110comprises a flexible sheet material having a multiplicity of pores.Preferably, the pores are from about 5 microns to about 60 microns insize. A flexible, strong polymer sheet material from which this seal isformed can be a Kevlar-like material, or it can be Goretex-likematerial, expanded PTFE, or other appropriate biocompatible material,such as polyether, polyurethane, or polycarbonate urethane membranes,can be used. Kevlar material is offered by the E. I. DuPont de NemoursCompany of Wilmington, Del. and Goretex material is offered by the W. T.Gore Company of Flagstaff and Phoenix, Ariz. The seal material may belined on its interior surface, its exterior surface, or both surfaceswith silicone or any suitable sealing material so as to render theflexible sheet material substantially impervious to the passage of anyfluid. A watertight seal is perfected when the seal 110 is glued orotherwise affixed to the legs 42, 44 and mediate portions of the legs72, 74 as suggested in FIGS. 1-3.

In the space beneath the seal member 110 and between the disc body 20and the concave surfaces of legs 42, 44, a lubricant may be used. Thelubricant used may be saline or an appropriate liquid or particulatematerial lubricant.

In an alternative embodiment, the watertight seal between theendoprosthesis 18 and adjacent parts of the anatomy can be provided bydeveloping a groove 402 completely encircling the periphery of each ofthe legs 42, 44. In this embodiment, the legs 72, 74 may be attached tothe circumferential groove member 402 by laser-welding or other suitablemeans. If the legs 72, 74 are of polymeric material, they may beattached by mechanical or adhesive techniques. Only one of the groovesis shown in FIG. 13. In this embodiment, the seal member 410 is providedwith a beaded edge 412 for each groove. Additionally, a retaining band415 is provided for each groove to retain the seal member 410 in groove402. The retaining bands 415 can be in the form of a biocompatiblemonofilament wire of, for example, stainless steel or titanium, asynthetic polymer cable or a braided wire cable. As shown in FIG. 11,each retaining band is crimped anteriorly by a crimping sleeve 420. Ofcourse, more than one crimping sleeve may be used, if necessary.Alternately, the retaining band is fastened by laser-welding. Althoughone sealing arrangement consisting of the groove, beaded edge andretaining band is shown in FIG. 14, it should be understood that thesealing arrangement on the concaval-convex leg of the other support isidentical in design and function.

In use, the seal member 410 is placed about the concaval-convex means30. The retaining bands 415 are then placed adjacent to the respectivegroove 402 and crimped anteriorly, thereby fitting the bands into thegrooves. Each beaded edge 412 prevents the slipping of the seal memberunderneath the retaining band. Thus, the retaining band, the groove andthe beaded edge all cooperate to provide a water-tight seal to preventthe migration of fluids between the endoprosthesis 18 and adjacent partsof the anatomy. Glue can also be used to affix the seal member to theconcaval-convex means 30 as a supplemental means for perfecting theseal.

In a first embodiment, the first legs 42, 44 are formed as an integralpiece with the respective second wings or legs 72, 74. In the alternateembodiment of FIG. 3, however, the first legs 42, 44 are hingedlyattached to the respective second legs 72, 74. A hinge 43, 73 isprovided at the point from which the second leg 72, 74 extends generallyperpendicularly to the first leg 42, 44. The hinge is not intended tofunction as such after being installed, but only during installation soas to allow better alignment of the endoprosthesis with the biologicallyvariable anterior surface of the respective vertebral body. Once theendoprosthesis is installed and affixed via the screw devices, the hingewill no longer move.

These hinges 43, 73 may take any of the several known forms. Each hingecan be a rod and socket hinge, a pin type hinge, or a slip jointfitting, or it can be a web or a membrane type hinge of metal orplastic.

The second wings or legs 72, 74 may be made of a suitable metal such astitanium or a polymeric material. Alternately, each leg 72, 74 includingits associated hinge element, can be made of a biodegradable polymericmaterial. When the legs 72, 74 are made of biodegradable material, thescrews 92, 94 used for affixing the legs to the adjacent bone structuremay be of the standard shoulder screw type in order to maintain firmfixation to the screw anchors 102, 104 after biodegradation of the legs72, 74.

Legs 72, 74 can be of a thin construction that allows some degree offlexibility so as to promote a better mating of the legs to the anterioraspect of the vertebral body 12, 14.

The legs can have a central closed oblong slot to accommodate a screw orother fixation device. Should a second endoprosthesis device be placedat an adjoining level, the leg 72, 74 would be placed on top of thecorresponding leg from the adjacent device. The screw 92, 94 or otherfixation device would then pass through the closed oblong slot of theoverlapping legs 72, 74.

In accordance with another aspect of the invention, the supports 32, 34are formed of a biocompatible metal which may contain chromium cobalt ortitanium. Surface roughening or titanium beading 112, 114 on theexterior surfaces 52, 54 of legs 42, 44 encourages positive bondingbetween the adjacent bone and the convex surfaces 52, 54. Over time,bone fuses or grows into the surface roughening, thereby adhering to thelegs 42, 44 in a rigid and strong manner.

As suggested in FIGS. 9 and 10, a prosthetic longitudinal ligament 250can be connected between the screws 92, 94 to limit motions betweenelements of the spine 10 in the area where the endoprosthesis 18 isimplanted. This strap 250 may be made of the Kevlar-like material or theGoretex-like material described above, or it may be made of any otherstrong biocompatible material. The ligament 250 may also be considered aspacer or cover for providing some degree of separation betweenoverlying soft tissues in the body and the anterior-most surfaces of thedevice. However, it is not designed for restricting or preventing motionin the disc body. A biodegradable washer can be provided around thescrews 92, 94 at a point between the strap 250 and the respective wingor leg 72, 74. When biodegradable washers are used, the screws 92, 94used for affixing the legs to the adjacent bone structure may be of thestandard shoulder screw type in order to maintain firm fixation to thescrew anchors 102, 104 after biodegradation of the washers.

When a ligament is used in the embodiment of the device having hingedlegs 92, 94, the prosthetic longitudinal ligament structure can compriseseveral parallel bands of material separated by approximately 10 mm.

In accordance with another aspect of the invention, multipleendoprosthetic disc units can be placed in series with a straddlinginterlock appendage providing stability and fixation as shown in FIG. 5.Entire portions of a patient's spine can be replaced by a series ofinterconnected endoprosthetic vertebral bodies and endoprosthetic discunits. FIGS. 6-8 show an upper natural vertebral body unit 312 to whichan upper endoprosthetic body 308 has been attached. A lower naturalvertebral body 314 has attached, at its upper end, an endoprostheticdisc unit 318. Between these endoprosthetic disc units 308 and 318 is anendoprosthetic vertebral body 320. As suggested by FIG. 7, theendoprosthetic vertebral body 320 need not be irregularly shaped incross sectional aspect; rather, manufacturing processes may suggest thatit have a circular cross-sectional shape. As show in FIGS. 6 and 8, thisendoprosthetic vertebral body 320 comprises a titanium element 321, towhich are attached the preformed upper and lower endoprostheticvertebral body upper and lower concaval-convex elements 322, 324. Eachconcaval-convex element 322, 324 is attached to the prosthetic vertebralbody 320, as shown in FIG. 7, by extending set screws 330 through thetitanium vertebral body 321 into a stem-like projection 331 extendingfrom each of the concaval-convex elements 322, 324. A hole 360 in thebody 320 accommodates the stem-like projections 331 of theconcaval-convex elements 322 and 324. The stem-like projection 331 ofthe concaval-convex elements 322 and 324 is used only in conjunctionwith a prosthetic vertebral body implant construction 320.

An ear 340 is affixed, as by weldments 341, to a leg 342 extending froma concaval-convex element 322 as illustrated in FIGS. 6 and 8. An anchor352 can be threaded into the endoprosthetic vertebral body 320, and ascrew 362 can be turned into the anchor 352 so as to rigidly assemblethe leg 342 to a leg 354 extending from the lower endoprosthetic discunit 318.

In an alternate embodiment, ear 340 could be replaced with abiodegradable washer around each of the screws 92, 94 at a point locatedbetween the strap 250 and the respective leg 72, 74. (FIG. 10.) Thewasher could be of a size to overlie and fix in place the interlockingwing leg from the adjacent intervertebral disc space. Alternately, ear340 (FIG. 8.) may be eliminated in favor of screws 92, 94 having a headof increased diameter so that the screw head engages and fixes both theslotted leg 72, 74 and the interlocking tongue leg.

The upper disc endoprosthesis 308, the endoprosthetic vertebral body320, and the lower disc endoprosthesis 318 can all be assembled andinterconnected as a unit before implantation in a patient's body whenindicated.

As also suggested in FIG. 6, the annular corners 372, 374 of naturalvertebral bodies 312, 314 each can extend irregularly radially outwardlyof the adjacent disc endoprosthesis 308, 318. However, the corners 382B,384B of the prosthetic vertebral body 320 do not generally extendsignificantly outside those disc units 308, 318, thus discouragingvertebral body engagement with and consequent abrasion or other damageto adjacent portions of the patient's natural anatomy. Preferably theendoprosthetic vertebral body 320 is not exactly right cylindrical inshape, but is rather slightly biconical; that is, the endoprostheticvertebral body 320 has a waist 390 of minimum radius R at an axialmedial point as suggested in FIG. 6.

According to yet another aspect of the invention, novel surgicalprocedures permit effective and permanent installation of theendoprosthetic vertebral body 320 and associated parts. First, a surgeonor medical technician develops information about the size, shape andnature of a patient's damaged vertebral body or bodies from radiographs,CT and/or MRI scans, noting specifically the anterior-posterior andlateral dimensions of the end plate of each involved vertebral body andthe vertical height of the anterior aspect of each involved vertebraland/or proximate vertebral body and vertical height of the mid portionof involved and proximate relatively normal intervertebral disc spaces.This information is transmitted by telephone, computer datalink ordocumentary transport to a specialized laboratory. That laboratoryconstructs one or more prosthetic assemblies of the sort shown in FIG. 6in conformity with the received information and this disclosure. Each ofthe assemblies can include a prosthetic vertebral body 321, and at eachbody end is a prosthetic disc 308, 318. Each prosthetic disc unitcomprises, in turn, the concaval-convex elements 30; the resilient body20 interposed between the concaval-convex elements; and the seal unit110 secured around the interior legs and resilient body. Thereafter, thecompleted and conformed assembly is implanted in the patient's spine 10.

When the unit or units have been received and the patient properlyprepared, the damaged natural spinal disc or discs and vertebral body orbodies are removed and the adjacent spinal bone surfaces are milled orotherwise formed to provide concave surfaces to receive the confrontingconvex surfaces 52, 54. Thereafter, the disc units and vertebral bodyare installed in the patient's spine.

To accurately locate the concaval-convex surfaces in the patient'sspine, holes 382A, 384A (FIG. 3) are precisely located and then formedin the bone structure using a measuring instrument centered in theevacuated natural intravertebral intervertebral disc space. These holesare then tapped to form female threads therein. When the threads havebeen formed, the anchors 102, 104 are implanted in the respective tappedholes, thereby creating an imaginary platform of reference pointslocated precisely with respect to the patient's spine. After the holeshave been formed and the anchors 102, 104 implanted, a bone surfacemilling jig (not shown) is affixed to the anchors 102, 104 and thedesired concave surfaces of predetermined shape are formed on theinferior and superior surfaces of the opposing vertebral bodies usingone of a selection of predetermined milling head or bit sizes.Thereafter, the bone milling jig is removed and the concaval-convexelements 52, 54 identical in shape to the milled surfaces 112, 114 areinserted between the distracted milled vertebral bodies 12, 14. Thedistraction device is then moved. The concaval-convex structures arethen attached by the same anchors 102, 104 to the bone, thus insuring aprecise and stable mate between the bone surfaces and the convexsurfaces 52, 54.

If necessary, a damaged implanted nucleus and/or gasket 24 can beremoved and replaced. This can be accomplished by slitting the seal 110;removing the annular gasket 24 and damaged nucleus 22, and replacingthem with new, undamaged elements. Thereafter, the seal 110 can bere-established by suturing or gluing closed the slit seal.

1. A vertebral An intervertebral disc endoprosthesis, comprising aresilient body formed of materials varying in stiffness from arelatively stiff exterior portion to a relatively supple centralportion; and concaval-convex elements at least partly surrounding theresilient body for retaining said resilient body in a position betweenthe concaval-convex elements, and wherein said concaval-convex elementseach comprise generally L-shaped supports, each support having a firstconcaval-convex leg, the first leg having an outer convex surface forengaging adjacent bone and a corresponding inner concave surface forretaining the resilient body, each support further having a second legextending generally perpendicularly to the first leg and adapted foraffixation to adjacent bone structures.
 2. A vertebral An intervertebraldisc endoprosthesis according to claim 1 wherein said resilient bodycomprises an annular gasket and a nuclear central portion.
 3. Avertebral An intervertebral disc endoprosthesis according to claim 2wherein the gasket extends about the nuclear central portion to encloseit within a thin layer.
 4. A vertebral An intervertebral discendoprosthesis according to claim 3 wherein the gasket, and the nuclearcentral portion, and the thin layer are molded together as one piece. 5.A vertebral An intervertebral disc endoprosthesis according to claim 1further comprising cannulated screw means for attaching theconcaval-convex element supports to adjacent bone structure.
 6. Avertebral An intervertebral disc endoprosthesis according to claim 5wherein said cannulated screw means comprises a screw, and a screwanchor seatable within bone structure and adapted to threadably receivethe screw.
 7. A vertebral An intervertebral disc endoprosthesisaccording to claim 6 wherein the screws terminate in the anchor.
 8. Avertebral An intervertebral disc endoprosthesis according to claim 6wherein the anchor has an open end and the screw proceeds through theopen end of the anchor and terminates in the bone of the vertebral body.9. A vertebral An intervertebral disc endoprosthesis according to claim1 further comprising a seal member attached to the concaval-convexelements and surrounding said resilient body.
 10. A vertebral Anintervertebral disc endoprosthesis according to claim 9 wherein saidseal member comprises a flexible sheet material having a multiplicity ofpores, the pores being from about 5 microns to about 60 microns in size.11. A vertebral An intervertebral disc endoprosthesis according to claim10 further including sealing means applied to said flexible sheetmaterial to render said flexible sheet material substantially imperviousto the passage of any fluid.
 12. A vertebral An intervertebral discendoprosthesis according to claim 11 wherein the sealing means issilicone.
 13. A vertebral An intervertebral disc endoprosthesisaccording to claim 9 wherein said concaval-convex elements and said sealmember collectively surround said resilient body with a watertight seal.14. A vertebral An intervertebral disc endoprosthesis according to claim2 wherein said annular gasket is relatively stiff and said nuclearcentral portion is relatively supple.
 15. A vertebral An intervertebraldisc endoprosthesis according to claim 1 wherein at least one of thesecond legs is hingedly attached to the respective first concaval-convexleg.
 16. A vertebral An intervertebral disc endoprosthesis, comprising aresilient body formed of materials varying in stiffness from arelatively stiff exterior portion to a relatively supple centralportion; and concaval-convex elements at least partly surrounding theresilient body between adjacent vertebral bodies for retaining theresilient body between adjacent vertebral bodies in a patient's spine,and wherein said concaval-convex elements each comprise generallyL-shaped supports, each support having a first concaval-convex leg, thefirst leg having an outer convex surface for engaging adjacent bone anda corresponding inner concave surface for retaining the resilient body,each support further having a second leg extending generallyperpendicularly to the first leg and adapted for affixation to adjacentbone structure, wherein at least the second leg is constructed oftitanium.
 17. A vertebral An intervertebral disc endoprosthesiscomprising a resilient nucleus, first and second rigid concaval-convexelements at least partly surrounding the nucleus, first and second legsformed, respectively, with the first and second rigid concaval-convexelements, first and second means for affixing the respective legs tovertebral bodies adjacent the concaval-convex elements and nucleus,longitudinal ligament prosthesis means extending between the legs of thefirst and second concaval-convex elements to inhibit undesirable motionof the vertebral bodies relative to one another, and biodegradablewashers positioned between the ligament prosthesis means and therespective legs.
 18. A vertebral An intervertebral disc endoprosthesiscomprising a rounded, resilient nucleus body convex on all surfaces andconcaval-convex elements, each concaval-convex element being ofrelatively constant cross-sectional thickness and having an outer convexsurface for engaging adjacent bone structure which has been milled tomate with the concaval-convex element outer convex surface, and acorresponding inner concave surface for engaging the rounded resilientbody, wherein lubricant is provided between the nucleus body and theconcaval-convex elements.
 19. A vertebral An intervertebralendoprosthesis comprising an integral disc unit, said unit including apair of confronting L-shaped supports having concaval-convex shapes ingiven legs, a resilient body interposed between the supports, and aflexible seal extending from one support to the other and sealing theresilient body within the supports inside a substantially watertightcompartment, further comprising a plurality of said integral disc units.20. The vertebral intervertebral disc endoprosthesis according to claim19 wherein each support includes a groove about its circumference. 21.The intervertebral disc endoprosthesis according to claim 13, whereinthe seal member comprises a flexible sheet secured to each of theconcaval-convex elements.
 22. The intervertebral disc endoprosthesisaccording to claim 19, further comprising a plurality of said integraldisc units.